| DAND Dental Implant System (K250176) | D.A.N.D. Metal Industries North, Ltd. | 2025-04-21 |
| Spectricept Skin and Wound Cleanser (K243875) | Spectrum Antimicrobials, Inc. | 2025-04-21 |
| Wearable breast pump (model S12A) (K243508) | Shenzhen TPH Technology Co., Ltd. | 2025-04-21 |
| VersaViewer (K243651) | GE Medical Systems SCS | 2025-04-21 |
| CHIKAI Nexus 014 (K243383) | Asahi Intecc Co., Ltd. | 2025-04-21 |
| K-ASSAY CRP (Ver.2) (K242170) | Kamiya Biomedical Company, LLC | 2025-04-18 |
| SofWave System (K250146) | Sofwave Medical, Ltd. | 2025-04-18 |
| handLITE (TN19S) (K250224) | iSMART Developments, Ltd. | 2025-04-18 |
| Zimmer Biomet Ceramic Heads (22.2mm diameter) (K250834) | Zimmer Biomet | 2025-04-18 |
| Wireless/ Wired X-Ray Flat Panel Detectors (K243734) | Allengers Medical Systems Limited | 2025-04-18 |
| DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution (K250459) | Technoflex Sas. | 2025-04-18 |
| Extension Feeding Set with ENFit™ Connectors (K250481) | SKY Medical, a.s. | 2025-04-18 |
| Acucy® Influenza A&B Test with the Acucy® 2 System (K241188) | SEKISUI Diagnostics, LLC | 2025-04-18 |
| PADLOCK CLIP EFTR Kit (00713229) (K250842) | STERIS Corporation | 2025-04-18 |
| LIAISON PLEX Gram-Negative Blood Culture Assay (K243013) | Luminex Corporation | 2025-04-18 |
| FROG (Filter Removal of Glass) (K240355) | Carrtech Corp | 2025-04-18 |
| PeriBeam® Pericardial Membrane (K240775) | Tamabio | 2025-04-18 |
| ULTRA 1040 (K241996) | Ecoray Co., Ltd. | 2025-04-18 |
| miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus (K242056) | Benq Materials Corporation | 2025-04-17 |
| Lacevo Wearable Breast Pump (Model S70) (K250829) | Shenzhen TPH Technology Co., Ltd. | 2025-04-17 |
| Minder System (DEN240062) | Epi-Minder Pty, Ltd. | 2025-04-17 |
| Ultimate rTMS (K243460) | Brain Ultimate, Inc. | 2025-04-17 |
| RELiZORB (100300/100301) (K250499) | Alcresta Therapeutics, Inc. | 2025-04-17 |
| VitalRhythm (K242129) | Vitalconnect, Inc. | 2025-04-17 |
| Luja Set (K250270) | Coloplast Corp. | 2025-04-17 |
| SimpleStitch Suturing System (K243750) | Envision Endoscopy | 2025-04-17 |
| FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (K250455) | Fluoptics Sas (A Getinge Group Company} | 2025-04-17 |
| FlowGuide (FG60F); GuidionShort (GS60F) (K242337) | Imds Operations B.V. | 2025-04-17 |
| EXULT Knee Replacement System (K250889) | Corentec Co., Ltd. | 2025-04-17 |
| CLARUS (700) (K243878) | Carl Zeiss Meditec, Inc. | 2025-04-17 |
| Dental Cone Beam Computed Tomography System (K243337) | Yofo Medical Technology Co., Ltd. | 2025-04-17 |
| Ultimate rTMS for OCD (M-series) (K243459) | Brain Ultimate, Inc. | 2025-04-17 |
| RayCare (2024A SP1) (K242992) | RaySearch Laboratories AB (PUBL) | 2025-04-17 |
| Medyssey Navigation System (K242806) | Medyssey Co, Ltd. | 2025-04-16 |
| LARALAB (K242500) | Laralab GmbH | 2025-04-16 |
| Nanox.ARC X (K250850) | Nano-X Imaging , Ltd. | 2025-04-16 |
| HEBE (NP0000763) (K241733) | Novasonix Technology S.L. | 2025-04-16 |
| Stellar M22 (K250809) | Lumenis Be, Ltd. | 2025-04-16 |
| Clarius Prostate AI (K243853) | Clarius Mobile Health Corp. | 2025-04-16 |
| MySegmenter (v2.0.0) (K242647) | Mysegmenter Technologies, Inc. | 2025-04-16 |
| DCM (PW-DCM) (K243513) | Pneumowave, Ltd. | 2025-04-16 |
| SwissMembrane X; SwissMembrane X Socket (K250833) | Geistlich Pharma AG | 2025-04-15 |
| Préime DermaFacial Collagen+ (K243055) | EMA Aesthetics , Ltd. | 2025-04-15 |
| Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set (K250824) | Boston Scientific Corporation | 2025-04-15 |
| TearCare MGX System (K242786) | Sight Sciences, Inc. | 2025-04-15 |
| SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (K250650) | Arineta , Ltd. | 2025-04-15 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL (K242658) | Thermo Fisher Scientific | 2025-04-15 |
| Electro Lube NXT (K242773) | Steris | 2025-04-15 |
| Skin Clinic Nitro Clear Wart Remover (K242932) | Cryoconcepts LP | 2025-04-15 |
| OptaBlate Radiofrequency (RF) Generator System (K250327) | Stryker Instruments | 2025-04-15 |
| Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (K250803) | Anhui Deepblue Medical Technological Co., Ltd. | 2025-04-15 |
| LapBox Power Tissue Containment System (K250212) | Ark Surgical | 2025-04-15 |
| Elfor-L (K243852) | Elfi-Tech , Ltd. | 2025-04-14 |
| STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (K250802) | Advanced Sterilization Products, Inc. | 2025-04-14 |
| Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (K250094) | Neuralynx, Inc. | 2025-04-14 |
| Any-Com Flow (K250823) | Mediclus Co., Ltd. | 2025-04-14 |
| AVAVA™ Skin Treatment System (K250402) | AVAVA, Inc. | 2025-04-14 |
| Merge Universal Viewer (MUV) (K250301) | Merge Healthcare Incorporated | 2025-04-14 |
| Dental Zirconia Ceramic (K250811) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-04-11 |
| OTOPLAN (K242120) | Cascination AG | 2025-04-11 |
| cobas liat SARS-CoV-2 v2 nucleic acid test (K243346) | Roche Molecular Systems, Inc. | 2025-04-11 |
| FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (K243260) | Fujifilm Corporation | 2025-04-11 |
| Dental Implant Unit (K242646) | Guilin Aesthedent Medical Instruments Co., Ltd. | 2025-04-11 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (K243537) | Xelite Biomed , Ltd. | 2025-04-11 |
| CT-132 (DEN240064) | Click Therapeutics, Inc. | 2025-04-11 |
| Canvas Dx (K243558) | Cognoa, Inc. | 2025-04-11 |
| Medline UNITE® REFLEX® Hybrid Nitinol Implant System (K243888) | Medline Industries, LP | 2025-04-11 |
| Oncospace (K242748) | Oncospace, Inc. | 2025-04-11 |
| AirSurgN Insufflator (10030/AirSurgN) (K242772) | SmartsurgN, Inc. | 2025-04-11 |
| Disposable ureteral access sheath (K243710) | Shenzhen Trious Medical Technology Co., Ltd. | 2025-04-11 |
| Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (K243857) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-04-11 |
| KLAXON (TWIST); KLAXON (TWIST R) (K250748) | Klaxon-Mobility GmbH | 2025-04-11 |
| CooperSurgical Milex® Pessaries (K250438) | CooperSurgical, Inc. | 2025-04-11 |
| Second Opinion Periapical Radiolucency Contours (K242600) | Pearl, Inc. | 2025-04-11 |
| Alma Harmony (K243044) | Alma Lasers, Inc. | 2025-04-11 |
| Atlantis® Abutments in Titanium (K250081) | Dentsply Sirona | 2025-04-11 |
| LED Curing Lights (DB686 HALO) (K243921) | Foshan Coxo Medical Instrument Co., Ltd. | 2025-04-11 |
| Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) (K242098) | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | 2025-04-11 |
| GBrain MRI (K250416) | Galileo Cds, Inc. | 2025-04-11 |
| Chlorine Sentinel II (K243898) | Nelson Environmental Technologies, Inc. | 2025-04-11 |
| Asiga DentaBASE (K243356) | Asiga Pty, Ltd. | 2025-04-11 |
| LED Curing Light (C01-X, C02-X) (K250009) | Premium Plus (Dongguan) Limited | 2025-04-10 |
| Tesera-k SC System (K242928) | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (K243953) | Vizionfocus, Inc. | 2025-04-10 |
| Skyway Anterior Cervical Plate System (K250486) | Kyocera Medical Technologies Inc. (KMTI) | 2025-04-10 |
| Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (K242089) | Jiangsu Ruifuda Medical Device Co., Ltd. | 2025-04-10 |
| XNY Disposable Gastric Calibration Tube (K250389) | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025-04-10 |
| syngo.CT LVO Detection (K243145) | Siemens Medical Solutions USA, Inc. | 2025-04-10 |
| NEAT 001 (K250058) | Brain Electrophysiology Laboratory Company, LLC | 2025-04-10 |
| FitboneTM Trochanteric (K250112) | Orthofix Srl | 2025-04-10 |
| cryoICE cryoXT cryoablation probe (cryoXT) (K250371) | AtriCure, Inc. | 2025-04-10 |
| EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K250177) | Philips Ultrasound, LLC | 2025-04-10 |
| Initia T3 Acetabular Hemispherical Shell System (K242045) | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| Vitrea CT VScore (K243240) | Canon Medical Informatics, Inc. | 2025-04-10 |
| cmAngio® (V1.6) (K250754) | Curemetrix, Inc. | 2025-04-10 |
| Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (K242561) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-04-10 |
| TriMed® Compression Screws (K243943) | TriMed, Inc. | 2025-04-10 |
| Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098) | Davol, Inc. | 2025-04-09 |
| FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (K243966) | Faceheart Corp. | 2025-04-09 |
| autoSCORE (V 2.0.0) (K243743) | Holberg Eeg AS | 2025-04-09 |